Regulatory Affairs Associate

at  Novartis

SUMMARY

Internal Role Title: Regulatory Affairs Associate Location: Singapore #LI-Hybrid About the Role: This role is to contribute as an integral member of Novartis Singapore RA team to support all regulatory activities for Novartis products. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.

Essential Requirements

• A minimum of Bachelor’s degree in health-related science, life science, Pharmacy degree desired
• 1-2 years of experience in regulatory affairs or related work experience.
• Proven track record of preparing and reviewing regulatory documentation, and handling submissions optimally
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products
• Good understanding of local regulatory environment, guidelines and processes for product registration.
• Ability to apply knowledge to general regulatory topics for projects assigned. Digital literacy with knowledge of MS Office applications
• Good interpersonal, organizational, negotiation and problem solving skills. Excellent verbal and written communication skill

Key Responsibilities :-

• Regulatory Strategy – Prepares submission dossiers for post-approval variations within agreed timelines. Maintains knowledge of latest regulatory requirements for therapeutic products. Establish and maintain good working relationship with the HSA.
• Regulatory Strategy - Acts as primary RA contact for the local Singapore team for the projects assigned. Ensures that new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned. Investigate regulatory compliance gaps with gap remediation plan development and implementation thereafter. Perform variation assessments when requested by global RA Franchise teams.
• Management of Regulatory Operations - Develop and maintain regulatory database(s) as required. Maintain and update regulatory files and records as required. Ensures compliance with local regulations, corporate policies and procedures. Prepares monthly project status updates.
• Management of Regulatory Operations - Checks and ensures promotional materials align with local regulatory requirements and corporate policies where required. Supports new drug applications and post-approval variations for Established Medicines.
• Collaboration with Cross-Functional Teams - Support process improvements and implementation of standard methodologies. Collaborates with local Quality Assurance (QA) on Quality matters matters (eg investigation of deviations and reporting them to relevant health authorities, when applicable), and Patient Safety (PS) on safety communication to HSA.
• Collaboration with Cross-Functional Teams - Collaborates with RA Business & Operational Excellence (BoE) on obtaining the Singapore Certificate of Pharmaceutical products (CPP) for the requesting country

Essential Requirements

• A minimum of Bachelor’s degree in health-related science, life science, Pharmacy degree desired
• 1-2 years of experience in regulatory affairs or related work experience.
• Proven track record of preparing and reviewing regulatory documentation, and handling submissions optimally
• Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products
• Good understanding of local regulatory environment, guidelines and processes for product registration.
• Ability to apply knowledge to general regulatory topics for projects assigned. Digital literacy with knowledge of MS Office applications
• Good interpersonal, organizational, negotiation and problem solving skills. Excellent verbal and written communication skills